Manager, Sterility Assurance

Bristol Myers Squibb UK

Devens, MA, United States
Base: $100,480 - $121,756; bonus/equity: + incenti...
50% onsite
Contamination control program oversight
Aseptic process validation
Environmental monitoring programs
The Manager, Sterility Assurance role is responsible for overseeing and driving continued compliance of the site contamination control program

Job Summary

  • The Manager, Sterility Assurance role is responsible for overseeing and driving continued compliance of the site contamination control program.
  • This role will directly collaborate cross-functionally with internal and external stakeholders to deliver exceptional results and drive continuous improvement of the sterility assurance control systems and processes at the site.
  • Our benefits include Health Coverage, Wellbeing Support, Financial Well-being and Protection, and Work-life benefits like Paid Time Off and Global Shutdown.

Matching Summary

The Manager, Sterility Assurance role is responsible for overseeing and driving continued compliance of the site contamination control program.

Salary

Base: $100,480 - $121,756; Bonus/Equity: Additional incentive cash and stock opportunities; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits

Skills & Requirements

Must-have

  • Contamination control program oversight
  • Aseptic process validation
  • Environmental monitoring programs
  • Clean utility monitoring programs
  • Regulatory compliance (FDA, EMA, USP)
  • Quality Risk Management (ICH Q9)

Nice-to-have

  • Continuous improvement initiatives
  • Cross-functional collaboration
  • Team-oriented and independent work
  • Adaptable and able to work under pressure

Key Requirements

  • Minimum 6 years experience in cGMP environment
  • Minimum 3 years in QC Microbiology/sterility assurance
  • Bachelor's degree in STEM or equivalent experience
  • Advanced understanding of Microbiology and aseptic processing
  • Knowledge of US and EU cGMP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter